Monday, June 30, 2014

A scientist who is currently with the UCSF Center for Tobacco Control Research and Education (home of Dr. Stan Glantz) is part of a research team that conducted an unethical experiment on hundreds of thousands of Facebook users, whose Facebook news feed content was manipulated without their informed consent in order to try to trigger their emotions.

The purpose of the experiment was to determine whether manipulation of an individual's Facebook news feed by blocking either positive or negative emotional content could affect the mood and emotional expression of that person. In short, the experiment sought to determine whether emotion is "contagious."

The paper defends its ethical standards by arguing that it "was consistent with Facebook's Data Use Policy, to which all users agree prior to creating an account on Facebook, constituting informed consent for this research."

Regarding the engagement of Facebook users in research, Facebook's Data Use Policy states the following:

"We use the information we receive about you in connection with the
services and features we provide to you and other users like your
friends, our partners, the advertisers that purchase ads on the site,
and the developers that build the games, applications, and websites you
use. For example, in addition to helping people see and find things that
you do and share, we may use the information we receive about you: ... for internal operations, including troubleshooting, data analysis, testing, research and service improvement."

The policy also states: "We give your information to the people and companies that help us
provide, understand and improve the services we offer. For example, we
may use outside vendors to help host our website, serve photos and
videos, process payments, analyze data, conduct and publish research,
measure the effectiveness of ads, or provide search results."

The Rest of the Story

This research violates basic ethical standards of informed consent for two reasons:

1. The subjects did not consent to participate in the study.

In fact, the subjects had no idea that they were part of an experiment involving artificial manipulation of their news feed for the purposes of potential inducing happiness or sadness as part of a research study. This potential use of their Facebook account is simply not mentioned in the Data Use Policy. The policy states that the information provided by users may be used for research purposes. It also states that the information may be shared with outside vendors to conduct research. However, nowhere does the policy state that users agree to intentional manipulation by Facebook staff for research purposes.

In other words, while the policy allows Facebook to collect and use user information for research purposes, it does not allow Facebook to conduct interventions in which it manipulates feeds shared with users in order to try to control their emotions as part of a research experiment.

Thus, before even getting to the issue of informed consent, the subjects in this research did not even consent to the research in the first place.

2. The subjects did not provide informed consent for their participation in the research.

Contrary to the assertion of the authors of this paper, simply being aware that the information one provides to Facebook may be used for research purposes does not constitute informed consent. The fact that users agreed to a Data Use Policy which notes that information may be used for research purposes does not, as the authors state, "[constitute] informed consent for this research."

In order to represent informed consent, there are several other elements which must take place. These are explained best by Professor James Grimmelmann over at The Laboratorium:

"The standard of consent for terms of service is low. But that
“consent” is a legal fiction, designed to facilitate online
interactions. (See Nancy Kim and Margaret Jane Radin’s books for more.) It’s very different from informed
consent, the ethical and legal standard for human subjects research
(HSR). The Federal Policy for the Protection of Human Subjects, a/k/a
the Common Rule, requires that informed consent include:

(1) A statement that the study involves research, an explanation of
the purposes of the research and the expected duration of the subject’s
participation, a description of the procedures to be followed, and
identification of any procedures which are experimental;(2) A description of any reasonably foreseeable risks or discomforts to the subject; …(7) An explanation of whom to contact for answers to pertinent
questions about the research and research subjects’ rights, and whom to
contact in the event of a research-related injury to the subject;(8) A statement that participation is voluntary, refusal to
participate will involve no penalty or loss of benefits to which the
subject is otherwise entitled, and the subject may discontinue
participation at any time without penalty or loss of benefits to which
the subject is otherwise entitled.

Facebook’s actual Data Use Policy
contains none of these, only general statements that “we may use the
information we receive about you … for internal operations, including
troubleshooting, data analysis, testing, research and service
improvement.” and “We give your information to the people and companies
that help us provide, understand and improve the services we offer. For
example, we may use outside vendors to … conduct and publish research.”
Neither of these comes close to a “description of the procedures to be
followed” or a “description of any reasonably foreseeable risks or
discomforts,” and the Data Use Policy doesn’t even attempt to offer a
contact for questions or an opt-out."
It is clear, then, that this study violated the principles of informed consent, as subjects did not provide informed consent prior to being enrolled in the research.
There is a provision for waiver of informed consent; however, the conditions for such a waiver were not met because: (1) the level of risk was not minimal; (2) the waiver did affect the rights and welfare of the subjects; (3) the research could still practicably have been carried out with informed consent; (4) subjects were not provided with information after the study to explain what occurred.

An Unethical Experiment
Because this research was funded by the federal government (by the Army Research Office, according to Cornell), it is subject to the human subjects research requirements. In addition, the involvement of two researchers at academic (federally-funded) institutions requires that the research be approved by an Institutional Review Board. Apparently, the research was approved by an academic IRB, a decision which I publicly question, for the above reasons.
The rest of the story is that despite the Common Rule and the intense efforts to try to prevent human subject violations in research, there are still occasional studies which find their way through the cracks. This is one bad example. It is an example of an unethical experiment that should never have been approved by an IRB in its current form because it blatantly violates the ethical principles of both consent and informed consent.

Friday, June 27, 2014

A number of policy makers - including several prominent U.S. senators - have called for a ban on e-cigarette flavorings in order to reduce their appeal to youth. Unfortunately, a new survey conducted among 10,000 adult vapers at E-Cigarette Forum suggests that such a ban would lead to a massive migration of adult vapers back to real, tobacco cigarettes.

The survey found that 74.4% of adult vapers most often use non-tobacco flavors, with the majority of these preferring fruit or dessert-related flavors. Only 22.9% prefer tobacco flavoring, and an additional 2.7% prefer tobacco flavoring combined with menthol. Fruit- and dessert-flavored electronic cigarettes represent approximately half of the market among the users surveyed.

The Rest of the Story

This survey has two major implications for public health regulation.

First, the results demonstrate that many adults - in fact the majority of them - do prefer flavored e-cigarettes. Thus, it cannot be assumed that just because an electronic cigarette company markets flavored products, it is intentionally trying to recruit youth users. This is a flaw that many anti-smoking advocates and groups have fallen into. Because the market appears to be dominated by flavored products, it does not logically follow that any company which is marketing flavored e-cigarettes is trying to attract kids to vaping.

Second, the results suggest that a ban on flavorings in e-cigarettes would have devastating consequences for the public's health. Specifically, it would likely cause a massive migration of vapers back to the severely toxic, real, tobacco cigarettes, and with that transition, all of the associated adverse health sequelae.

A further reason not to ban flavorings in e-cigarettes is that youth who experiment with these flavored products are almost certainly much less likely to progress to smoking. It is difficult to imagine a youth transitioning from a cherry e-cigarette to a Marlboro. In a sense, flavored e-cigarettes may actually be protective of youth transitioning from vaping to smoking. The tastes are so vastly different, and the e-cigarette use probably accustoms youth to a flavored taste that they are just not going to get with a real cigarette.

For all of these reasons, I believe that the current evidence does not support the FDA placing a ban on flavorings in electronic cigarettes. Such an action would, ironically, have devastating overall consequences for the public's health, both among youth and adults.

Thursday, June 26, 2014

Yesterday, I reported that Drs. Stan Glantz and Simon Chapman issued defamatory attacks against Lorillard for running an inappropriate blu e-cigarette commercial (the robot sex ad). The truth is that Lorillard had nothing to do with the ad, which was produced in 2010, well before Lorillard acquired blu.

The Rest of the Story

Today, I reflect on what this story demonstrates about the scientific bias that is apparent in the anti-smoking movement, particularly among researchers like Dr. Glantz, who has repeatedly misinterpreted scientific studies in order to skewer electronic cigarettes.

What the story demonstrates is that Dr. Glantz has a pre-determined set of conclusions about electronic cigarettes and the tobacco companies' role in inappropriately marketing these products to addict a new generation of kids. When presented with information, he jumps to an immediate interpretation and conclusion that supports his pre-determined schema. Instead of exercising critical judgment and objective evaluation of the evidence, he immediately twists the facts to support his pre-existing position. Dr. Glantz is just one example of a phenomenon that characterizes a number of researchers and tobacco control groups that are vehement opponents of electronic cigarettes for ideological, rather than valid scientific reasons.

In psychology, this phenomenon is known as confirmation bias. A 2010 Boston Globearticle describes this phenomenon and explains how when people are affected by this bias, they twist new facts that run counter to their position in order to fit with their pre-determined conclusions, rather than change their positions in line with the new information.

In the article, Joe Keohane writes:

"Recently,
a few political scientists have begun to discover a human tendency
deeply discouraging to anyone with faith in the power of information.
It’s this: Facts don’t necessarily have the power to change our minds.
In fact, quite the opposite. In a series of studies in 2005 and 2006,
researchers at the University of Michigan found that when misinformed
people, particularly political partisans, were exposed to corrected
facts in news stories, they rarely changed their minds. In fact, they
often became even more strongly set in their beliefs. Facts, they found,
were not curing misinformation. Like an underpowered antibiotic, facts
could actually make misinformation even stronger." ...

“The
general idea is that it’s absolutely threatening to admit you’re
wrong,” says political scientist Brendan Nyhan, the lead researcher on
the Michigan study. The phenomenon — known as “backfire” — is “a natural
defense mechanism to avoid that cognitive dissonance.”

For this reason, I am discouraged about the possibility that people like Dr. Glantz and Dr. Chapman will change their minds about the potential utility of e-cigarettes if further evidence accumulates to demonstrate the benefits of these products. The science is simply not going to matter to them. Hopefully, the science will matter to the FDA.

Wednesday, June 25, 2014

On his tobacco blog, Dr. Stan Glantz links to a quite inappropriate advertisement for blu electronic cigarettes, attacking Lorillard for using this approach to promote e-cigarette use. He claims that this is part of Lorillard's ongoing strategy, accusing Lorillard of stooping to this low tactic to recruit youth to vaping. The ad depicts a robot having sex with a woman and then afterwards shunning a cigarette and offering an e-cigarette instead.

On his Twitter feed, Dr. Simon Chapman also attacked Big Tobacco for running this ad, accusing Lorillard of "viraling" this ad "to teens."

Of course, I agree with both Dr. Glantz and Dr. Chapman that the ad is quite inappropriate.

The Rest of the Story

The problem is that Lorillard did not create this ad, had no part in its development, and is not running the ad now. In fact, Lorillard has absolutely nothing to do with the ad.

The truth is that the ad was created independently as part of a viral video contest. Apparently, blu did not do anything to dissociate itself from the ad. However, the ad was produced in 2010, two years before it was purchased by Lorillard. Thus, Lorillard had nothing to do with the ad.

The rest of the story, then, is that Glantz and Chapman are making a false accusation.

How, then, do they get away with this?

The answer is that in the anti-smoking movement, you don't need to be honest and truthful. As long as your intentions are good, you can get away with lying and with making false and defamatory accusations. The ends are all that matter, and if you use defamatory means to reach those ends, it's perfectly acceptable.

I, too, was disturbed by this ad and was going to write a blog post attacking it. However, it was quite apparent to me that this is not something that Lorillard would run. So before jumping to attack Lorillard, I did a little research and confirmed that it was not a Lorillard ad. In fact, it wasn't even really a blu company ad, since the company did not produce it (although they still had some association with the ad and did not disavow any relationship with it). My colleagues - Glantz and Chapman - were so excited about the opportunity to attack Lorillard for promoting e-cigarettes to youth that they failed to exercise even a minimum of due diligence in checking the facts first. (The complete story is here).

In law, there is a term used to refer to what Glantz and Chapman are doing here. It is called defamation.

As much as I condemn this advertisement, I also condemn the defamatory tactics that Glantz and Chapman are using to falsely accuse Lorillard of producing the ad.

In the study, investigators examined measures of acute heart function using echocardiography among 36 smokers and 40 vapers, before and after using either a cigarette or e-cigarette. The researchers found that cigarette smoking adversely affected acute heart function. Electronic cigarette use had no effect on any of the measures examined.

The results were summarized as follows:

"This is the first study to examine the acute effects of electronic cigarette use on myocardial function. No adverse effects on LV [left ventricular] myocardial function were observed after using electronic cigarette with nicotine-containing liquid for 7 minutes. On the contrary, significant changes in diastolic function parameters were found after smoking 1 tobacco cigarette."

The authors conclude as follows:

"This study provides the first clinical evidence that electronic cigarettes have less acute adverse effects on myocardial function when compared to tobacco cigarettes."

The Rest of the Story

This study adds to the abundant evidence that electronic cigarette use is much safer than smoking.

Given that abundant evidence, it is inappropriate for many anti-smoking advocates and groups to continue to tell the public that we don't yet know whether vaping is safer than smoking.

Sadly, the FDA itself - in its proposed deeming regulations - concluded that we do not yet know enough to determine whether vaping is any more dangerous than smoking. I find it horrific that the FDA - the agency which is going to
supposedly be using science to make informed, evidence-based decisions
regarding tobacco products - is not sure that cigarette smoking is any
more hazardous than the use of fake cigarettes that contain no tobacco,
involve no combustion, produce no secondhand smoke, have much lower
levels of carcinogens, and have been found to acutely improve the health
of smokers who switch to them.

With that conclusion, the FDA has unfortunately destroyed its scientific credibility. It has demonstrated that it will be ideology, and not science, that dictates the regulation of tobacco and nicotine-containing products in this country.

The rest of the story is that the next time you hear an organization claim that vaping may not be any safer than smoking, you will know that the group has no scientific credibility. It's just sad to think that the FDA is one of those groups.

Monday, June 23, 2014

Last Wednesday, the Senate Committee on Commerce, Science, and Technology held a hearing on the marketing of electronic cigarettes. Several senators, including Jay Rockefeller (D-WV), Barbara Boxer (D-CA), and Richard Blumenthal (D-CT) harshly attacked the two electronic cigarette company executives who testified before the committee, calling them liars who are doing harm to the public and comparing them to the Big Tobacco executives of the past.

According to an article at Time.com: "In a hearing Wednesday afternoon that harkened back to the famous
congressional Big Tobacco hearings two decades ago, Senators on the
Commerce, Science and Transportation Committee eviscerated electronic
cigarette executives Jason Healy, CEO of blu eCigs (owned by tobacco
company Lorillard), and Craig Weiss, CEO of NJOY, leaders of the two
leading e-cig brands."

The harshest questioning came from Senators Richard Blumenthal, Barbara Boxer, and Jay Rockefeller:

"I think we
have seen this movie before," Senator Richard Blumenthal said. "It is
called big nicotine comes to children near you and you are using the
same kinds of tactics and promotions and ads that were used by big
tobacco and proved so effective." ...

"At the end of her time to question, Boxer said: “Mr. Healy and Mr.
Weiss, you can con yourself. But we don’t know if this product gets
people off cigarettes yet, so don’t think you are doing some great
mission. Don’t say you care about kids,” said Senator Boxer. “Don’t be a
part of this, because you’ll regret it.”"

"But the harshest words came from Senator Jay Rockefeller (D- West
Virginia), who said to the executives: “I’m ashamed of you. I don’t know
how you go to sleep at night. I don’t know what gets you to work in the
morning except the color green of dollars. You are what is wrong with
this country.”"

The Rest of the Story

Actually, it is the behavior of Senator Rockefeller that is what is wrong with this country. And it is Senator Rockefeller who should not be able to sleep at night.

There is a part of this story that was not revealed at the hearing, and it is time to reveal it now at the Rest of the Story.

While Senator Rockefeller attacks the electronic cigarette companies for targeting kids with flavored products that he claims is going to addict and harm them, he is hiding from the public the truth:

1. There are, in fact, thousands of kids who are becoming addicted to flavored nicotine products which are going to eventually kill them.

2. Those products are not electronic (fake) cigarettes.

3. Those products are real tobacco cigarettes.

4. Those products are menthol-flavored cigarettes.

5. In 2009, Senator Rockefeller sponsored and supported legislation that protected menthol cigarettes by exempting them from the flavored cigarette ban in the Family Smoking Prevention and Tobacco Control Act.

Thus, the rest of the story is that Senator Rockefeller protected Big Tobacco and helped them to continue to see the color green of dollars by voting to exempt menthol cigarettes from legislation that banned every other flavor. In other words, he sold out to Philip Morris, agreeing to this exemption that would allow Big Tobacco to continue to addict America's children with flavored cigarettes. Nearly 50% of youth smokers in the U.S. become addicted to smoking via menthol cigarettes.

The bottom line is that Senator Rockefeller is a typical politician and a classical hypocrite. He is also completely disingenuous. Were he truly committed to protecting kids from addiction to flavored tobacco products, he would never have sold out to Philip Morris by sponsoring and supporting legislation that exempted menthol from the cigarette flavoring ban. Even now, if he truly cared about the actual health of children, instead of attacking the e-cigarette industry, he would have devoted his time and energy to crafting and sponsoring legislation to ban menthol from cigarettes.

The truth is that Senator Rockefeller pretended to be committed to protecting the health of our nation's children, but instead, he was actually protecting Big Tobacco profits by exempting menthol from the flavoring ban. The Tobacco Act banned every imaginable flavor that was not actually being used in cigarettes (e.g., cherry, strawberry, banana, and pineaple), yet it exempted the one flavor (menthol) that was actually being used to addict children to a lifetime of smoking - a greatly shortened lifetime for many of them.

This is actually what is wrong with our country: politicians who pretend to be acting in the public's interest but who are actually acting in interest of our nation's largest and most profitable corporations.

And it is not the CEOs of Blu or NJOY who shouldn't be able to sleep at night, it is Senator Rockefeller. How can he sleep each night, knowing that his actions are responsible for thousands of kids who, in the past four years, have become addicted to menthol cigarettes because he failed to act responsibly and are eventually going to die prematurely because of his sellout to Philip Morris?

Senator Boxer also has no business excoriating the e-cigarette executives as she, too, sold out to Big Tobacco by supporting the legislation which exempted menthol from the cigarette flavoring ban. And she, too, has failed to sponsor legislation - now or any time in the past four years - that would correct the problem now by banning menthol cigarettes.

Senator Blumenthal is also a phony and a hypocrite as he, too, has failed to sponsor legislation to ban menthol cigarettes (he was not a Senator in 2009 so did not vote for the original menthol exemption).

Beyond the blatant hypocrisy of Senators Rockefeller, Boxer, and Blumenthal, they are also wrong in their assertion that blu and NJOY are heavily marketing their products to kids. In fact, the evidence suggests otherwise.

The most telling point is that blu does not offer its disposable products in flavors other than tobacco
(classic) or menthol. Note that the disposable products are the ones
that are relevant to children because they are the cheapest and most
likely to be used by kids. It is very unlikely that kids are going to
unleash the money required to purchase the charging kit. Blu offers
rechargeable starter kits that do contain flavorings, but
does not offer the disposables in flavors other than tobacco or menthol. Kids would have to shell out a minimum of $70 for the starter kit.

In contrast to Senator Rockefeller's assertion, blu is actively avoiding the marketing of candy-flavored electronic cigarettes to children, as it is not offering candy-flavored disposable electronic
cigarettes. This is perhaps the clearest signal that blu is not marketing flavors to children. It should be obvious to
the senators, if if they put any thought into the issue, that the best way to judge blu's intentions is to examine
the differences between their starter kit flavors (the ones which
require you to shell out 70 bucks) and their disposable flavors (the
ones which kids are most likely to use). In fact, while the starter kit
flavors do include candy varieties, the disposables do not. This is a
clear sign that Lorillard is not interested in offering candy-flavored
electronic cigarettes to the youth market.

In fact, Blu was already offering these candy-flavored varieties prior
to its acquisition by Lorillard. It is understandable while Lorillard
maintained these flavors, since it wouldn't want to lose existing Blu
customers. But it is telling that Lorillard chose not to extend this
candy-flavored approach over to its disposable e-cigarette segment. If
the senators' assertion was correct, then Lorillard would most certainly be
selling candy-flavored disposable electronic cigarettes.

Similarly, NJOY does not appear to be marketing to kids. The most telling point is that in its internet sales, the company does not sell flavored e-cigarettes (only traditional tobacco and menthol). And of course, if NJOY were after kids, it would certainly offer the flavored varieties online, since kids are more easily able to obtain these products online, where age verification is not required, than in-store, where it is.

The truth, in fact, is that NJOY's explicit value proposition is that it is trying to eviscerate the combustible cigarette market. While NJOY has the courage and values to stand up and work for the decimation of combustible cigarettes, that is something which Senators Rockefeller, Boxer, and Blumenthal do not have the fortitude to do. Instead, they have supported the institutionalization and protection of the tobacco cigarette market and are doing everything they can to protect real cigarettes from potential competition from far safer, fake ones.

Wednesday, June 18, 2014

Organizations that oppose electronic cigarettes, such as the CDC and FDA, and anti-smoking advocates who oppose these products, like Dr. Stanton Glantz, have been arguing that electronic cigarettes are a gateway to youth smoking. The CDC has gone so far as to claim that its own survey demonstrates that youth are starting with electronic cigarettes and then moving on to smoke real tobacco cigarettes. The CDC has warned the public that e-cigarettes lead to a lifetime addiction to smoking among our nation's children.

Fortunately, there is a simple way to evaluate this hypothesis, at least on a preliminary basis, prior to waiting for the results of longitudinal studies. Enough youth are experimenting with electronic cigarettes, and the increase in youth e-cigarette use has been dramatic and sustained enough, that if the gateway hypothesis were correct, we would be starting to see an increase in smoking prevalence among youth due to the many new smoking initiates that were converted from e-cigarette experimentation to smoking.

The Rest of the Story

The rest of the story is that new data from the CDC itself show that the smoking rate among U.S. high school students dropped significantly in 2013, reaching the lowest level in the history of the survey (the Youth Risk Behavior Survey), which began in 1991.

Despite the tremendous proliferation of e-cigarette experimentation among youth, with a doubling of use from 2011 to 2012 alone, the CDC data show that youth smoking prevalence (among high school students) fell dramatically, from 18.1% in 2011 to 15.7% in 2013. This is a 13.3% decline in smoking prevalence over a two-year period. It is also the largest drop in youth smoking prevalence measured by this survey over the past decade.

These data all but destroy the gateway hypothesis. They demonstrate that at the current time, the evidence simply does not support the assertion that the proliferation of e-cigarette use among youth is leading to increased smoking initiation. Electronic cigarettes are not leading to a lifetime addiction to cigarette smoking among our nation's youth.

Tuesday, June 17, 2014

A new study published today in the journal Tobacco Control demonstrates why the FDA's proposed regulatory approach for electronic cigarettes makes no sense. In fact, the new research shows why the FDA's approach would be a complete bureaucratic nightmare, while not actually protecting the public's health.

In this study, the authors study attempted to determine the number of electronic cigarette products on the market, both in terms of the number of different brands and the number of different flavors. Using comprehensive internet searches, the researchers found as follows:

"By January 2014 there were 466 brands (each with its own website) and 7,764 unique flavors. ... Newer brands offered more flavors per brand (49 vs. 32) ... ."

The Rest of the Story

The basic framework that the FDA has proposed to regulate e-cigarettes is that every product on the market (except a very few that were already on the market as of February 2007) must submit a new product application. These applications must demonstrate to the FDA that the introduction of the product to the market is appropriate for the public's health.

Because products are substantially equivalent only if they pose no different issues of public health, and because flavorings can affect product efficacy and safety, it is probable that every different flavor of every different brand must submit a separate application. Thus, at a minimum, there are going to be at least 466 x 49 applications, or 22,834 required applications.

The FDA's Center for Tobacco Products simply does not have the capacity to review 22,000 new product applications. After all, it has taken more than 4 years for the agency to even begin to process the more than 3,500 substantial equivalence applications submitted by tobacco companies, and as of this date, there are still thousands of those applications pending. It is easy to see that the proposed deeming regulations would create a bureaucratic nightmare.

Moreover, the proposed regulations do nothing to directly regulate product safety. For years to come, we would still have exploding batteries, leaking cartridges, and packaging that is not child-proof. After all, it is going to be a minimum of one year before the regulations are promulgated, another two years before the applications are due, and probably 5-6 years before the 22,000 new product applications can be processed (and that is only if the FDA acts in an unprecendentedly speedy fashion). So we're talking 8-9 years before we see any meaningful safety improvements.

Instead of this insane regulatory approach, the FDA should scrap the requirement for product applications and should simply promulgate basic safety standards that ensure minimum, uniform requirements for product safety. If the agency allows for a 12-month grace period, we could expect to see these requirements actually take effect within two years.

In addition to ensuring basic safety, such regulations would also address issues such as the presence of formaldehyde in some e-cigarette brands and would regulate the product to minimize the known harmful by-products which have been identified in some e-cigarettes. These by-products are avoidable. We know this because some brands on the market (such as Vuse and NJOY) have been tested and shown to have no detectable/quantifiable levels of any hazardous byproducts.

As the agency learns more about these products in all their diversity, the basic safety standards could be enhanced.

I can only hope that this new study will help the FDA realize the folly of its proposed approach to electronic cigarettes and develop a new set of regulations that directly set standards for the safety of the product.

Monday, June 16, 2014

Many tobacco control advocates have asked me why, as a harm reduction supporter, I am always talking about the use of electronic cigarettes to help people quit smoking, rather than the use of smokeless tobacco products.

Tony Gwynn's tragic death at age 54 from repeated smokeless tobacco use is the reason why. While it is not common, traditional smokeless tobacco use is clearly associated with oral cancer. In addition, there is little evidence that as marketed and used in the United States, these products are helping a substantial proportion of smokers to stay off cigarettes.

For these reasons, I believe that electronic cigarettes are a much more viable option as a harm reduction approach for smoking cessation.

In a comment submitted to the FDA, Dr. Stan Glantz has asserted that in terms of pulmonary effects, the use of electronic cigarettes may not be any less hazardous than smoking conventional cigarettes.

Of course, this is the same thing as stating that cigarette smoking may be no worse than vaping in terms of its effects on pulmonary function.

Dr. Glantz writes: "Evidence that e-cigarette aerosol has the same effects on an important
measure of lung function as cigarette smoke undermines the assumption
that e-cigarettes are uniformly less risky than conventional cigarettes."

This assertion is based on a new study which found that electronic cigarette use, like smoking, results in reduced levels of exhaled nitric oxide. As Dr. Glantz writes:

"The paper, "Short-term effects of electronic and tobacco cigarettes on
exhaled nitric oxide," by Sara Marini, et al, just published in Toxicology and Applied Pharmacology
(Volume 278, Issue 1, 1 July 2014, Pages 9–15), reports important data
showing that nicotine e-cigarettes, non-nicotine e-cigarettes, and
conventional cigarettes all have similar effects of depression of
exhaled nitric oxide."

Based on this single study, Dr. Glantz concludes: "the FDA must be extremely careful about assuming that e-cigarettes uniformly pose less risk than conventional cigarettes."

Stated another way, Dr. Glantz is cautioning the FDA against assuming that e-cigarettes are safer than conventional cigarettes in terms of their effects on lung function.

The Rest of the Story

In my opinion, Dr. Glantz's conclusion from this study is unscientific, illogical, and extremely damaging and destructive to the FDA's consideration of this issue as well as to the public's appreciation of the severe hazards of cigarette smoking.

Dr. Glantz is simply wrong. There is abundant evidence which demonstrates that while vaping does cause some degree of respiratory irritation (and probably triggers a bit of inflammation), it is far safer than smoking and has far less of an effect on lung function.

In fact, in a study by Flouris et al., the investigators found that real cigarettes, but not the fake ones, had a significant detrimental effect on pulmonary function, measured by spirometry. This study documents that while active smoking has immediate, clinically meaningful effects in reducing lung function, electronic cigarettes do not.

In order to draw the conclusion that Dr. Glantz drew in his comment, one would have to completely ignore this study. Obviously, Dr. Glantz has done exactly that. He has based his comment on one narrow study and ignored the rest of the literature.

But it doesn't end there.

The Marini study demonstrates that electronic cigarettes do lead to a reduction in exhaled nitric oxide, which suggests that they have a mild respiratory irritant effect and induce some inflammation in the airways. This is a finding which has been reported previously in a number of studies. It is not surprising because propylene glycol is known to be a mild respiratory irritant.

But what is the clinical meaning of this effect? In order to find that out, one needs to conduct studies with longer-term end points.

Well, Polosa et al. have conducted exactly such a study. They examined the changes in asthma symptoms among smokers who continue to smoke versus those who switch to electronic cigarettes. These investigators reported that in contrast to real cigarettes, the fake ones result in actual harm reversal. Lung function, asthma control, and asthma symptoms were significantly improved among patients who switched from regular cigarettes to electronic cigarettes. These improvements were even observed among patients who became dual users of both real and fake cigarettes.

It is clear from the overall evidence that electronic cigarettes are not as risky as tobacco cigarettes in terms of acute effects on lung function. On this issue, Dr. Glantz's comment is simply wrong.

The very idea that one would extrapolate from a study finding that vaping, like smoking, reduces exhaled nitric oxide levels to the conclusion that smoking may be no more hazardous than vaping in terms of its acute pulmonary effects defies scientific logic. It also shows a misunderstanding, or at least a misinterpretation of the meaning of exhaled nitric oxide findings.

The finding of reduced exhaled nitric oxide is an indication that an exposure is causing some sort of inflammatory effect on cells lining the respiratory tract. It doesn't mean anything more or less than that. You can't take two exposures - each of which causes respiratory tract inflammation - and make the statement that the effects of both exposures are equal. Risk posed by an exposure depends on many other factors, including the degree of inflammation induced, the reversibility of the effect, the nature of the exposure, the chronicity of the exposure, etc.

To understand how ridiculous Dr. Glantz's extrapolation is, consider some of the other exposures that also cause reductions in exhaled nitric oxide:

1. Taking an exam

When students take their final exam in my course, they are all experiencing acute effects on their respiratory tracts. In fact, if you were to measured their exhaled nitric oxide levels, you would find that there is a significant reduction, just as is observed with smoking.

In fact, this is precisely what Trueba et al. demonstrated in a study of changes in exhaled nitric oxide levels in 41 healthy college students.

Would one therefore conclude that taking an exam is just as risky, in terms of respiratory effects, as smoking a cigarette? Apparently, Dr. Glantz would draw such a conclusion. But it is easy to see why this is an inappropriate conclusion. And we would never disseminate messages to the public that smoking is no more hazardous than taking an exam.

Can you imagine if the tobacco companies used the same logic as Dr. Glantz? They would, according to his scientific reasoning, be perfectly honest in communicating to the public statements like this:

"Smoking is not uniformly more hazardous than simply taking an exam."

"In terms of acute effects on respiratory function, active smoking is exactly equivalent to the effects of taking a math test."

"Smoking is no more hazardous than taking an exam in terms of its acute respiratory effects."

To be completely honest, Trueba et al. actually found that not only did taking an exam affect nitric oxide levels, but it also produced decreases in lung function measured by spirometry. This is something that has not been observed for electronic cigarettes.

2. Feeling sad

Trueba et al. also found that higher depressive mood was associated with greater reductions in exhaled nitric oxide.

Using Dr. Glantz's reasoning, the cigarette companies would be perfectly honest in putting out headlines stating:

You can see the quality of the scientific reasoning we are dealing with.

Hopefully, the FDA will not be swayed by this nonsense.

It is worth noting that the conclusions which Dr. Glantz is disseminating are destructive because they undermine decades of public education about the severe hazards of smoking. If the public thinks that smoking is only as risky as vaping, then it is likely that many smokers will decide to continue smoking rather than quitting using electronic cigarettes. And many ex-smokers who have quit with electronic cigarettes may return to smoking, thinking that they might as well since they are not getting any definite health benefit from having made the switch.

Thursday, June 12, 2014

In a comment submitted to the FDA regarding its proposed e-cigarette deeming regulations, a trio of UCSF scientists argue that it is premature to declare that there is a continuum of risk among nicotine-containing products, including tobacco cigarettes and electronic cigarettes.

They write: "The idea of a “spectrum of risk” or “continuum of risk” among tobacco
and nicotine delivery products is logical. However at this time it is a
hypothesis lacking sufficient empirical evidence to use as a basis for
regulatory decisions. ... The
FDA should not predicate regulatory actions on the assumption that any
tobacco or nicotine delivery product is substantially safer than another
until the improved safety profile has been demonstrated by a
substantial body of peer-reviewed scientific research."

They conclude: "Taken together, these studies demonstrate unequivocally that products
and devices that deliver respirable particles and nicotine are
inherently dangerous. The “Spectrum of Risk” is an unproven hypothesis
with potentially deadly effects on the public health. FDA should not
deem any tobacco or nicotine product to be safer than another, until it
is proven to be safer through a substantial and consistent body of
peer-reviewed scientific research."

The Rest of the Story

These scientists are arguing that it is premature to declare that there is any difference in risk between a tobacco cigarette, which burns tobacco, and an electronic cigarette, which contains no tobacco and involves no combustion, but merely heats nicotine in a solution of propylene glycol and glycerin.

In other words, they are telling the FDA that at the present time, they cannot conclude that cigarette smoking is any more harmful than vaping.

What a damaging and irresponsible public statement to make!

They are essentially telling smokers that they are perhaps just as well off continuing to smoke cigarettes as switching to electronic cigarettes because we are not sure that the e-cigarettes are any safer.

We have an epidemiological term for what we would call it were a physician to make precisely such a statement to a patient: ...

... malpractice.

There is absolutely no question that vaping is safer than smoking and that smokers who switch to electronic cigarettes are improving their health. To suggest otherwise is scientifically irresponsible, in my opinion. It undermines years of public education about the dangers of cigarette smoking. Even Big Tobacco would not claim that their products are as safe as non-combusted, non-tobacco-containing, electronic cigarettes.

However, these UCSF scientists are making precisely such a claim.

These researchers conclude, in the same comment, that electronic cigarettes cause heart disease, heart attacks, and pulmonary disease. There is inadequate evidence for any of those assertions.

The ultimate irony is that while these researchers do not believe there is sufficient evidence to conclude that smoking is any more harmful than vaping, they do believe there is enough evidence to conclude - already - that vaping causes heart disease, heart attacks, and pulmonary disease. Even the most hardened e-cigarette opponents, including Glantz himself, have not gone that far.

Wednesday, June 11, 2014

In a submission to the FDA regarding the proposed deeming regulations, Stan Glantz and colleagues have called on a government ban on truthful speech by electronic cigarette companies: namely, stating that electronic cigarettes are safer than tobacco cigarettes. The authors of this comment want the FDA to expressly prohibit electronic cigarette companies from informing consumers that vaping is safer than smoking.

In fact, one of the complaints in the comment is that "E-cigarette companies are marketing e-cigarettes as healthier alternatives to cigarette smoking."

Glantz believes that informing consumers that e-cigarettes are safer than smoking will increase the appeal of e-cigarettes to youth, and on that basis, he wants the truth to be suppressed. The comment recommends that FDA ban "indirect health claims," which presumably means claims that e-cigarettes are safer than real cigarettes.

The Rest of the Story

It is perfectly reasonable for the government to intervene to prevent companies from making false or misleading claims to the public. Even severe infringement of free speech by corporations may be justified in the case of preventing the deception of consumers. However, there is little justification for prohibiting companies from telling consumers the truth, and there is no justification for suppressing the truth when those facts are the most pertinent information that the consumer needs to know in order to make an informed decision about using the product.

There is little question that electronic cigarettes are much safer than tobacco cigarettes (even Glantz himself admits that). And further, there is little question that the most important piece of information consumers need in deciding whether to continue to smoke real cigarettes or switch to the fake ones is that the fake ones don't contain or burn tobacco and are therefore much safer than the real tobacco cigarettes.

Why would we want to suppress the provision of this information to the public? And what justification is there for a government-mandated suppression of the truth?

While I agree with Stan on virtually every aspect of the regulation of cigarette marketing, we part ways when he advocates the suppression of the truth.

Tuesday, June 10, 2014

I have long argued that tobacco control advocates who have financial ties to Big Pharma must disclose these ties if they opine about national strategies for electronic cigarette regulation because these ties represent a conflict of interest. My argument was based on the premise that electronic cigarettes represent a major form of market competition with pharmaceutical cessation aids and that drug companies therefore have a financial interest in seeing electronic cigarettes squashed.

Today, I reveal that this speculation about pharmaceutical financial interests in the demise of e-cigarettes was not just speculation, but it has now been confirmed.

According to an article in the London Times, GlaxoSmithKline - a major player in the pharmaceutical smoking cessation industry - has lobbied vigorously on behalf of stringent electronic cigarette regulation in the European Union. Specifically, a leaked memo apparently showed that Glaxo was telling policymakers that electronic cigarettes could be a gateway to smoking and that these products should be regulated as medicines, not as a type of nicotine or tobacco product.

According to the article: "One of the world’s biggest pharmaceutical companies has warned lawmakers that
electronic cigarettes could act as a “gateway to tobacco”. The leaked correspondence from GlaxoSmithKline, whose nicotine patches, gums
and lozenges are being undermined by the burgeoning e-cigarette market,
reveals the opposition from the pharmaceutical industry to impending
regulation of e-cigarettes across the European Union. The pharmaceutical industry wants medicines licences to be mandatory for
e-cigarettes, as they are for nicotine products. Instead, the EU is set to
introduce a system in which e-cigarette companies can opt in for medicines
regulation or be regulated in a similar way to traditional cigarettes."

Christopher Snowdon reported the details of the story here back in February. He wrote:

"This is a blatant attempt at rent-seeking by an obvious vested interest.
We know that the pharmaceutical industry has been lobbying hard to
hamper the growth of e-cigarettes so it comes as no surprise to find
Glaxo using the tired old gateway argument.
The truth is that e-cigarettes will only "seriously disadvantage" the
NRT market if they work better as quitting aids. In my experience—and
the experience of countless other people—e-cigarettes are much better
substitutes for smoking. If they were really a "gateway" to smoking,
e-cigarettes would be good for companies like Glaxo as they would
create more smokers (NRT companies need there to be smokers just as
much as cigarette companies do)."

Snowdon also noted that the UK National Smoking Cessation Conference was funded by GlaxoSmithKline and Pfizer. He wrote:

"As usual, both these companies are main sponsors of the
conference—apparently there is no problem having corporations that are
vociferously opposed to the most promising development in smoking
cessation paying for a conference about smoking cessation."

The Rest of the Story

Financial interests in Big Pharma must now be recognized as conflicts of interest for any organization or individual who is offering opinions about national strategy, policy, or regulations regarding electronic cigarettes. Therefore, the authors of all scientific articles regarding electronic cigarettes must disclose any financial interests with pharmaceutical companies. Furthermore, organizations must also disclose any financial ties to Big Pharma when they offer recommendations regarding electronic cigarette policy.

Unfortunately, there have been numerous violations of this disclosure standard, as several commentators on electronic cigarette policy have failed to disclose their Big Pharma ties in published articles. I have highlighted many of these stories on my blog, but for one demonstrative example, see my column on failed disclosures by an individual and an organization in the New York Times debate on electronic cigarettes.

Another inexcusable conflict of interest is the fact that Mitch Zeller, the director of the FDA's Center for Tobacco Products and therefore the chief author of the proposed electronic cigarette regulations, came to the FDA directly from a consulting job with GlaxoSmithKline and therefore has a severe conflict of interest regarding the electronic cigarette issue.

Moreover, several former members (and one current member) of the FDA's Tobacco Products Scientific Advisory Committee have (or have had) financial conflicts of interest with Big Pharma, and thus are not in a position to offer opinions about national tobacco product regulation in the context of this expert advisory panel.

And finally, it appears that most of the national tobacco control conferences continue to be funded by pharmaceutical companies. There is no way that these conferences can be objective about smoking policy, especially regarding electronic cigarettes and smoking cessation, when they are funded by Big Pharma.

Monday, June 09, 2014

Recently, Stan Glantz and colleagues called for a ban on electronic cigarette flavorings. Other anti-smoking groups have also urged the FDA to implement a ban on the use of flavors in electronic cigarettes. I have already explained why such an intervention makes no sense because it essentially represents a ban on electronic cigarettes, prevents brand differentiation, and greatly decreases the appeal of these products, thus forever protecting the market share of tobacco cigarettes. Today, I explain why the flavors in electronic cigarettes probably play a role in deterring youth smoking. Thus, I provide another argument for why the FDA should not ban electronic cigarette flavors.

The Rest of the Story

The argument being made by the CDC, as well as many other anti-smoking groups and advocates, is that electronic cigarettes are a gateway to youth smoking. In other words, youth who have never smoked before are going to try electronic cigarettes, become addicted to nicotine, and then move on to tobacco cigarette smoking.

This argument might have some plausibility if electronic cigarettes were "starter cigarettes." In other words, if electronic cigarettes were much milder versions of tobacco cigarettes, with milder tobacco flavor, then it might be expected that youth could advance from an electronic cigarette to a real one. Electronic cigarettes with tobacco or menthol flavoring, for example, might be expected to get kids used to the taste of a tobacco cigarette and thus to promote cigarette smoking initiation.

However, is the same thng true of a flavored e-cigarette?

Based on the experience of vapers, there is strong and compelling evidence that the flavors lead vapers away from tobacco taste, not towards it. Vapers consistently report that the use of the flavors helps them lose their taste for tobacco and makes it more difficult for them to return to cigarette smoking.

One would expect a similar experience with youth e-cigarette experimenters. Once they get used to the sweet flavors of electronic cigarettes, it is hard to fathom that they could then be drawn to the harsh taste of tobacco. It is difficult to imagine a youth switching from a gummy bear flavored e-cigarette to a Marlboro.

In fact, it could well be that flavored electronic cigarette use inhibits youth smoking by making it much less likely that a youth is going to enjoy his or her first experience with real tobacco cigarettes. The oral and respiratory tracts that are used to fruit or candy flavors are most likely not going to be able to tolerate or enjoy the harsh taste and sensation of a tobacco cigarette. For this reason, it is entirely conceivable that the use of electronic cigarettes might actually be a deterrent to cigarette smoking.

However, this deterrent effect - if present - depends upon the availability of flavored electronic cigaretttes. If only tobacco and menthol e-cigarettes were to be allowed on the market, this deterrent effect could no longer take place.

For this reason, the FDA should think long and hard before jumping into a decision to ban the flavors in electronic cigarettes. It is possible that despite encouraging experimentation among some nonsmoking youth, flavored electronic cigarettes may actually have a net positive effect on the public's health by serving as an overall deterrent to youth smoking.

In the absence of data demonstrating that flavored electronic cigarettes are serving as a gateway to youth smoking, there is no public health justification for a ban on flavors in electronic cigarettes, and such a measure could cause more public health harm than good.

Friday, June 06, 2014

Stan Glantz and several colleagues have submitted a comment to the FDA calling for a complete ban on the use of flavors in electronic cigarettes.

The authors write: "FDA should immediately under the current rulemaking establish a product standard prohibiting flavors in e-cigarettes... ."

The Rest of the Story

The rest of the story is that Glantz and colleagues are essentially calling for a ban on all existing electronic cigarettes. Why? Because every electronic cigarette contains flavors. In fact, the presence of flavors is the only distinguishing characteristic of different brands of e-liquids or cartridges.

The ingredients of virtually every electronic cigarette liquid on the market are:

1. Nicotine
2. Propylene glycol and/or glycerin
3. Flavors

That's it! That's basically all there is.

For example, let's take a look at the ingredient list for some of the major e-cigarette brands on the market:

Virtually every electronic cigarette consists of nicotine, PG and/or VG, and flavorings, plus or minus a little water and perhaps citric acid. It is the flavor that makes the brand. In most cases, even the "tobacco"-flavored electronic cigarettes contain flavorings.

It's easy to see that a ban on flavors is essentially a ban on electronic cigarettes. It would ban virtually every electronic cigarette currently on the market. Moreover, it would mean that there could only be one type of electronic cigarette liquid, which would have to contain just nicotine and propylene glycol and/or glycerine, and there would be no way for different liquids to distinguish themselves. The product would completely lose its appeal to smokers and the cigarette market would be protected forever.

Such a regulatory action would remove the ability of companies to market their products and would eliminate the taste and appeal of the product, handing the entire cigarette category over to Big Tobacco.

In my opinion, a ban on flavors in electronic cigarettes would completely destroy the electronic cigarette market. If the FDA is going to ban the flavors in e-cigarettes, then it might as well just ban the product entirely.

Why would public health practitioners like Dr. Glantz and his colleagues support an action that will end the great electronic cigarette experiment and permanently hand the entire cigarette market over to Big Tobacco?

If any of my readers can find out, please let me know because it is baffling to understand why a long-time anti-smoking advocate like Stan would want to protect cigarettes from the most serious competition they have ever faced. If this flavoring ban is enacted, Stan will have the rare role of being not only the hero of the tobacco control movement but the hero of the cigarette promotion movement as well.

Tuesday, June 03, 2014

Last week, the Northampton (MA) Board of Health enacted regulations to strengthen its smoke-free air law. Specifically, the Board of Health extended the smoking ban to include: (1) all public parks and athletic fields; (2) all private clubs; and (3) the use of e-cigarettes in all public places, including parks.

It may sound like a strong, courageous action from a Board of Health that is being guided by the solid, consistent principle that all nonsmokers should be protected from exposure to secondhand smoke, period.

The Rest of the Story

Not exactly.

While the Board of Health was "courageous" enough to ban smoking at all private clubs, it was not "courageous" enough to similarly ban smoking at the city's own public club -- the Garden House Banquet Hall at Look Park.

Hidden in the regulations is an exemption that allows for a designated smoking area at the Garden House Banquet Hall, even though that area is located in Look Park, which is a municipal park at which the regulations supposedly ban smoking.

In other words, this is a special exemption put in place for what are clearly political, rather than public health purposes.

And what might those political purposes be?

Well, consider that by banning smoking at all private clubs but creating an exemption for the city's Banquet Hall, it could potentially establish a competitive advantage for the city-owned facility over private facilities in competition for business from people looking for venues for celebrations.

Fortunately, the fine print in the regulations did not escape the attention of the ACLU, which is challenging this special interest exemption.

The ACLU is also challenging the inclusion of electronic cigarettes in the regulations, as it seems absurd to ban the use of e-cigarettes in all parks, given the lack of any evidence that vaping in a park poses any substantial public health threat.

The Northampton Board of Health may not have created public health regulations that have any consistency or science base. However, they have created an excellent entry for the 2014 Hypocrisy of the Year Award.

Do anti-smoking groups have any sense of perspective? The answer appears to be "no" based on the latest news out of the Garden State.

New Jersey GASP is pushing for state legislation that would ban smoking everywhere on college campuses, including in remote alleys and parking lots and would ban electronic cigarette use on a remote area of a beach, but allow smoking to continue unencumbered in crowded Atlantic City casinos, where hundreds of workers are suffering debilitating diseases because of their secondhand smoke exposure.

GASP may want a 100% smoke-free environment in public places, but it said nothing in the entire news interview about the real public health problem in New Jersey: secondhand smoke exposure in the state's casinos. Moreover, while GASP is promoting legislation to get rid of every last wisp of smoke on entire college campuses and to ban electronic cigarette use in remote areas of a beach, the legislation that the group is supporting allows smoking to continue unabated in the state's casinos, where hundreds of workers are suffering from real diseases brought on by secondhand smoke exposure.

Were I a casino worker in New Jersey, I would be pissed off that GASP is supporting legislation to protect the public from the imaginary public health threat of deadly secondhand smoke exposure on beaches and in college parking lots, while that very legislation does nothing to protect me from the very real threat I face every day from the devastating effects of 40 hours or more per week of high levels of secondhand smoke exposure.

According to ANR: "The average level of cotinine (metabolized nicotine) among
nonsmokers increased by 456% and the average levels of the carcinogen NNAL
increased by 112% after four hours of exposure to secondhand smoke in a
smoke-filled casino with a "sophisticated" ventilation system."

In contrast, I'm not aware of a single study showing that banning smoking everywhere on college campuses or on beaches is necessary to protect the public from any substantial public health threat.

Perhaps I wouldn't be so bothered by this attempt to protect the public from every last wisp of smoke on beaches if state politicians had some integrity and were willing to also protect the state's citizens who need it the most: New Jersey's casino and gaming workers.

The rest of the story is that GASP as well as New Jersey politicians who are pretending to show a genuine concern for the public's health are actually showing little but hypocrisy and political cowardice. In 2014, I don't see any need for this kind of public health nonsense.

Monday, June 02, 2014

The black box warning for Chantix, which is required by the FDA to be placed on this smoking cessation drug made by Pfizer, notes the following:

"All
patients being treated with CHANTIX should be observed for
neuropsychiatric symptoms including changes in behavior, hostility,
agitation, depressed mood, and suicide-related events, including
ideation, behavior, and attempted suicide. These symptoms, as well as
worsening of pre-existing psychiatric illness and completed suicide,
have been reported in some patients attempting to quit smoking while
taking CHANTIX in the postmarketing experience. ... Advise patients and
caregivers that the patient should stop taking CHANTIX and contact a
healthcare provider immediately if agitation, hostility, depressed mood,
or changes in behavior or thinking that are not typical for the patient
are observed, or if the patient develops suicidal ideation or suicidal
behavior."

The black box warning, then, advises physicians to
observe patients being put on Chantix for "suicide-related events,"
including "suicide."

The requirement by the FDA that this black box warning be placed on Chantix is based on the agency's assessment of hundreds of cases of suicides that occurred in patients who had recently been treated with the drug, as well as thousands of cases of other serious adverse neuropsychiatric symptoms associated with the use of Chantix. In making a decision to require a black box warning, the agency takes into consideration the likelihood that the observed association between the drug and the adverse effects is a causal one.

In my opinion, it is the responsibility of the company that markets the drug in question not to undermine, refute, or publicly challenge the black box warning once the FDA has made a decision to require this warning. It is the FDA's scientific judgment, not that of the pharmaceutical company, that should be the final word in making the decision about whether or not a black box warning is required and what the black box warning should state. If the company refutes the black box warning publicly once it has been required, then it is essentially thumbing its nose at the FDA and substituting its own scientific judgment for that of the agency.

The Rest of the Story

Responding to a news media request for a quote regarding a murder/attempted suicide case in which the defendant claims he acted as a result of depression induced by Chantix, Pfizer publicly refuted the FDA's required black box warning and denied that there is any reliable evidence that Chantix can cause severe neuropsychiatric events, such as suicide or similar violent actions.

"Pfizer released a statement defending the smoking cessation medication.
“Chantix has been studied extensively and there is no reliable
scientific evidence that the medicine causes serious neuropsychiatric
events like the violence in this case,” a Pfizer spokesperson told ABC 10 News."

In my view, this refutation and undermining of its own black box warning violates accepted standards of pharmaceutical company conduct, and should prompt either penalties or the removal of the drug from the market. If Pfizer is going to publicly undermine the required black box warning, then clearly that warning is not adequate to protect consumers and the FDA must either penalize Pfizer so that it desists from this behavior or pull the drug from the market since it is becoming clear that the company is undermining that warning in the eyes of the public.

This is the equivalent of a cigarette company refuting the required warnings that are made on a cigarette package. The cigarette companies are free to fight the cigarette warning labels as they are being considered, but once a federal body requires those warnings, the companies must not act to undermine the required warnings. In this case, Pfizer's actions are more grievous than those of a cigarette company undermining a package warning because the black box warnings are required by a federal regulatory safety agency, rather than by a Congressional act. More specifically, the black box warnings are an official part of the formal approval of the marketing and sale of the drug. The company may not sell the drug without the warning. By publicly undermining and refuting the warning, the company is essentially violating the terms of the drug's approval.

Had there been no reliable evidence that Chantix may cause serious neuropsychiatric events like suicide or other violent behavior, then why did the FDA conclude - after reviewing the evidence - that a black box warning is required?

And why did the FDA require Pfizer to warn doctors that patients taking the drug should be "observed for
neuropsychiatric symptoms including changes in behavior, hostility,
agitation, depressed mood, and suicide-related events, including
ideation, behavior, and attempted suicide ... as well as
worsening of pre-existing psychiatric illness and completed suicide."

By publicly refuting the black box warning, Pfizer is literally spitting in the face of the FDA. This is not appropriate. The company should either be penalized and forced to discontinue its campaign of refutation of the black box warning findings, or the drug should be pulled from the market due to a finding that the company has violated the terms of the drug's approval.

Of course, the FDA is not going to take either of these actions. Because it knows where its bread is buttered. In contrast, however, the very same agency is prepared to pull thousands of electronic cigarettes from the market even though there really is no reliable evidence of any harms being caused by these products (with the exception of exploding batteries, which the agency should immediately address via a manufacturing standard requirement).

About Me

Dr. Siegel is a Professor in the Department of Community Health Sciences, Boston University School of Public Health. He has 32 years of experience in the field of tobacco control. He previously spent two years working at the Office on Smoking and Health at CDC, where he conducted research on secondhand smoke and cigarette advertising. He has published nearly 70 papers related to tobacco. He testified in the landmark Engle lawsuit against the tobacco companies, which resulted in an unprecedented $145 billion verdict against the industry. He teaches social and behavioral sciences, mass communication and public health, and public health advocacy in the Masters of Public Health program.